Canadian clinical trial registry

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Study Description

This study is to find the appropriate dose as well as to assess the safety and effectiveness of a drug called quizartinib for children with relapsed or refractory acute myeloid leukemia (AML) with a certain mutation called FLT3-ITD. Quizartinib is a drug designed to specifically block the FLT3 protein when it is abnormal in a leukemia cell.

Inclusion Criteria

• Children 1 month to 21 years of age
• Acute myeloid leukemia that has come back or is not responding to current treatment
• Presence of the FLT3-ITD mutation in the leukemia
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

In this study, researchers are trying to learn more about the safety of the combination of study medicines Avelumab and Lenvatinib, and how well they work for children and young people with central nervous system tumours where previous treatment have not worked.

If you/your child participate in this study, you/they will be asked to join one of the two parts.

Part 1 will help us learn the best dose of the drug to take, and in Part 2, we will use the information obtained in Part 1 to continue to give the study drug and monitor how it is working.

Inclusion Criteria

• Patients must have a confirmed diagnosis of a high-grade brain tumour
• Patients must be between the ages of 2-18 years old
• Patients must have a cancer that has come back (relapsed) after a previous treatment
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

The purpose of this study is to test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

• Age <12 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

• Age 12 to less than 25 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Some patients may be eligible even if they have already received another drug blocking NTRK in the past
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This clinical trial is testing a new treatment for children and young adults with aggressive brain tumors, including DIPG and high grade glioma with a specific genetic change (H3 K27M mutation). The treatment combines standard radiation therapy with a new medicine called selinexor, which may help stop cancer cells from growing and shrink tumors. Patients receive radiation for 5-7 weeks and take selinexor pills weekly during and after radiation for up to two years. The study will first find the safest dose of selinexor and then test how well it works. MRIs and follow-up visits help monitor progress. Researchers hope this treatment will improve outcomes for these difficult-to-treat brain tumors.

Inclusion Criteria

Pre-Enrollment

1. Age: Patients must be 25 years old or younger.
2. Diagnosis: Must have a suspected or confirmed diagnosis of DIPG or newly diagnosed high-grade glioma (HGG) that hasn’t spread.
3. Consent: A parent or guardian, or the patient, must sign a consent form.
4. Samples (non-DIPG tumours): Tumour samples from surgery or biopsy need to be submitted soon after the procedure (ideally within 5 days).

Main Enrollment

1. Age: Patients must be between 1 and 21 years old.
2. Diagnosis:
   • DIPG: Must meet specific imaging or biopsy criteria.
   • HGG: Must be newly diagnosed, without certain genetic mutations.
3. Patients need to be in good overall health with normal lab results and no severe symptoms.
4. Enrollment must happen within 31 days of diagnosis or surgery.
5. A signed consent form is required.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

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Study Description

This clinical trial studies the side effects of a medication called CLR131. This medication is a targeted radiopharmaceutical, which means it acts like radiation therapy, but is given intravenously as an infusion. 

CLR 131 is designed to target cells with cancer rather than cells without cancer. The main goal of this study is to determine what is the safe amount of medication to give to children with cancer that has come back or is not responding to treatment.

Inclusion Criteria

• Age between 10 and 25 years
• High Grade Glioma that has come back (relapse) or not improved despite treatment (progression)
• Must meet all bloodwork requirements
• Patient must be up and about at least 60% of their waking hours
• Patient must be willing to comply with study visit requirements and sign a consent form 

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

This study is to test the safety of a drug called lurbinectedin in solid tumours that have come back (relapsed) or not responded to treatment (refractory). It is conducted in 2 parts, Phase 2 will further assess this drug in participants with Ewing sarcoma specifically.

Inclusion Criteria

• Participant must meet the following age requirements:
  • Phase 1 Part 1: participants must be ≥ 2 to < 18 years of age.
  • Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
  • Phase 2: participants must be ≥ 2 to ≤ 30 years of age.
• Participant has a confirmed solid tumor (For phase 2, Ewing Sarcoma)
• The participant is up and about for more than half their waking hours
• Participant meets all lab value requirements during the screening period
• Participant weighs at least 15kg
• Must not be pregnant (if applicable), and/or must be on an acceptable birth control method 
• Must sign informed consent and agree to attending all required study assessments 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team 

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Study Description

In this study, a drug called tocilizumab will be used to treat patients with a brain tumour called Adamantinomatous Craniopharyngioma between the ages of 1 and 25 years old. This cancer is currently treated with surgery and radiation, which can impact the quality of life for patients - instead, this drug interacts with IL-6, which is a type of protein in your body called a cytokine. By blocking the function of IL-6, this study explores if the drug is safe and effective at inducing a tumor response.

Inclusion Criteria

• Participants must be ≥ 12 months and ≤ 25 years of age at the time of study enrollment.
• Participants must have a confirmed diagnosis of adamantinomatous craniopharyngioma that has previously been treated
• Participants must be up and about at least half of their waking hours
• Must have recovered from the effects of any prior therapies
• Participants must meet the organ function and lab work requirements 
• Participants and/or their parents or legal authorized representatives must sign a written informed consent.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

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Study Description

VICTORY is an early phase study for patients under 25 years who have a type of brain tumor called low grade glioma (LGG) that coms back or gets worse (recurrent or progressive). To participate on this study, the LGG must have certain genetic changes called CRAF or BRAF alterations.

The study has two parts:

Phase A: We are figuring out the best dose of a combination of two medicines, vinblastine and tovorafenib. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Phase B: After we find the right dose in Phase A, we'll test how well the combination of these drugs works. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Patients will be in the study for about two years unless their tumor gets worse (disease progression), they have bad side effects or they decide to withdrawal from the study.

Inclusion Criteria

• Patients must be less than or equal to 25 years of age at the time of enrollment
• Patient and/or their parent/guardian must sign an informed consent form to be enrolled on study
• Patients must have a diagnosis of low grade glioma (LGG) with a genetic alteration called BRAF or CRAF alteration that has come back (recurrent) or not responded to previous treatment (progressive)
• Patients must have completed at least 1 other therapy prior to enrollment on this study and recovered from its effects.
• Patients must have adequate performance status (daily activities which they are able to do) 
• Must have adequate organ function in bone marrow, kidneys, liver, heart and thyroid
• Willingness of male and female patients with reproductive potential to use double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 180 days following the last dose of study drug. 
• Ability to swallow tablets or liquid, or gastric access via a nasal or gastric tube.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.